Experience

CALYX

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Associate Project Manager

  • May 2022 - Present



IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Senior Lab Project Service Coordinator

  • Jun 2021 - Jun 2022

  Essential Functions: Perform generic, routine study duties and tasks that are applicable across designated projects and Protocol phases, including but not limited to: receipt of site lists, entering site data into the database, flowcharts, ordering laboratory kits, and monitoring the day to day running of designated projects (i.e. patient specimen management receipt, pending lab analysis, and test result approvals and reports). Provide regular Project Status reports to the Project manager, CRA, Sponsor and the company as applicable. Support the Project Manager with the administrational tasks of the study (e.g. action item tracking, meeting minutes, change logs, etc.). Act as backup support for the Project Manager during their times of absence, including leading client communication and management study activities. Coordinate and communicate with relevant stakeholders as instructed by the study Project Manager. Proactive lines of Communications: Interact with other functional areas and/or vendors to resolve problems, enhance processes and service delivery. Liaise with other departments and support services (e.g. Logistics Department, courier services) in order to expedite the transportation of patients’ laboratory specimens. Work closely with other members of the Global Project team, identifying issues that may impact the study, take action and/or make recommendations to improve processes and timelines for study completion. Liaise with study Sponsor as required. Lead internal or external client calls, discussions and/or tasks for regional studies as required Investigator Training and Meetings: If needed, represent the company at Investigator/ Monitor meetings and/or client meetings. Administer study training to sites, CRA and/or sponsors as applicable. Conduct Kick-Off/Project Launch meetings or other meetings on behalf of the Project Manager as needed. Develop meeting and training materials as needed (e.g. Investigator Meeting, portal training, etc.). Show less



Parexel

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• • Jan 2020 - Jun 2021

  project Coordination from site start-up to close out phase. Giving access to systems at right person at right time. Dealing with systems LIKE EDC (Rave), INFROM, My Trails, Project View, IMPACT. Accessing PL/FL/CRA/ISM, follow-up for EDC submission with investigators or site numbers. Supporting to site start up system analyst for feasibility and site initiation phase.● Responsible for the set-up and maintenance of trial(s) in Clinical Trial Management Systems Update data, timelines, milestones, EC/HA authorizations, etc. for Countries and Sites on an ongoing basis. Coordinate with CRO CRAs to obtain the Monitoring Visit dates and trip reports data in required templates and ensure that the data is updated in CTMS● Responsible for ensuring all key documents are present and filed as appropriate in Trial Master File (TMF)● Undertake and take ownership of a full range of duties relevant to support client deliverable or internal reporting and documentation requirements. Assigned to either specific responsibilities within single projects or work as part of a centralized team to complete defined activities for project teams worldwide. Provide administrative support for a project, program or partnership. ● Update and maintain Internal/External systems and or databases with attention to detail. Run reports from Internal/External systems and provide to project teams. Prepare Metrics and status reports based on information from various systems. Analyze reports as instructed and provide results to project teams. Own Trusted Delegate responsibilities within a partnership to provide/revoke accesses for PAREXEL team members to Internal/External systems. ● Own Project/Program access management Show less

• • Nov 2017 - Jan 2020

  Project Coordination from site start-up to close out phase. Giving access to systems at right person at right time. Dealing with systems LIKE EDC (Rave), INFROM, My Trails, Project View, IMPACT. Accessing PL/FL/CRA/ISM, follow-up for EDC submission with investigators or site numbers. Supporting to site start up system analyst for feasibility and site initiation phase.• Undertake and take ownership of a full range of duties relevant to support client deliverables or internal reporting and documentation requirements • Assigned to either specific responsibilities within single projects or work as part of a centralized team to complete defined activities for project teams worldwide • Provide administrative support for a project, program or partnership. • Update and maintain Internal/External systems and or databases with attention to detail. • Run reports from Internal/External systems and provide to project teams. • Prepare Metrics and status reports based on information from various systems • Analyze reports as instructed and provide results to project teams. • Own Trusted Delegate responsibilities within a partnership to provide/revoke accesses for PAREXEL team members to Internal/External systems. • Own Project/Program access management • May attend regular Internal Progress/Metric Review meetings and provides feedback for recommending improvements. •Responsible for the set-up and maintenance of trial(s) in Clinical Trial Management Systems Update data, timelines, milestones, EC/HA authorizations, etc. for Countries and Sites on an ongoing basis. Coordinate with CRO CRAs to obtain the Monitoring Visit dates and trip reports data in required templates and ensure that the data is updated in CTMSResponsible for ensuring all key documents are present and filed as appropriate in Trial Master File (TMF) Show less



GlobalData Healthcare

• United Kingdom
• Information Services
• 300 - 400 Employee

• • Apr 2017 - Nov 2017

  • Responsibilities: Secondary research on, Principal Investigators, Drug Indications. Checking for the duplication of trials, principal investigator and drugs which present in the tool and dumping total information to the tool.• Report writing on the trail which mainly deals with the Phases of trails, Drug indications, Patient indications, what of type trail like single blind or double blind.• Comparison of the API to the Sponsor drug and Nature of the drug and Side effects are reported.Primary research on trail locations. Show less

• • Nov 2015 - Mar 2017

  • Responsibilities: Secondary research on, Principal Investigators, Drug Indications. Checking for the duplication of trials, principal investigator and drugs which present in the tool and dumping total information to the tool. • Report writing on the trail which mainly deals with the Phases of trails, Drug indications, Patient indications, what of type trail like single blind or double blind.• Comparison of the API to the Sponsor drug and Nature of the drug and Side effects are reported.Primary research on trail locations. Show less



Biophore India Pharmaceuticals Pvt. Ltd.

• India
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Project Management

  • Jul 2015 - Nov 2015